A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	45 - Any
Updated:	8/8/2018
Start Date:	March 2011
End Date:	March 2012

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the
safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome
(ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized
to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time
on study treatment is 20 weeks.

Inclusion Criteria:

- Adult patients, >/=45 years of age

- Patients admitted to the hospital for acute coronary syndrome (ACS)

- Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion Criteria:

- Symptomatic congestive heart failure (NYHA Class III or IV)

- Clinically significant heart disease requiring coronary artery bypass grafting,
cardiac transplantation, surgical valve repair/replacement during the study

- Uncontrolled hypertension

- Uncontrolled diabetes

- Severe anemia

- Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C;
eg niacin, fibrates)

We found this trial at

sites

Clinical Trial Facility in Saint Cloud Minnesota

Saint Cloud, Minnesota

from

Saint Cloud, MN